Sue Boyce (Queensland, Liberal Party) Share this | Hansard source

I was interested to hear Senator Carol Brown tell us that the government is committed to due process in this move on PBS cost recovery. The government has a reputation for being all about process, for being about reviews, inquiries, workshops and talkfests. Yet, the opposition’s objection to this bill is about the lack of process. There are no draft regulations and still there is no explanatory memorandum for the draft regulations. Witness after witness when they spoke at our inquiry said that they had no idea what this was going to mean in practical terms. How was it going to work? No-one knew. Where were the draft regulations? It is a fundamental flaw in the legislative process of this government that there are no draft regulations. You only need to look at the government majority report from the Senate Standing Committee on Community Affairs inquiry. It says:

The committee shares stakeholders’ concerns that the proposed regulations, containing the detail of the implementation of the cost recovery arrangements, were not available for examination during the course of this inquiry. As a result, it has been difficult for the committee to appropriately assess the implications of the proposed arrangements.

Yet the government happily claims that it would be hypocritical not to vote for this legislation. The government majority committee report says, ‘We cannot appropriately assess the implications of the proposed arrangements.’ The report from the government members of the community affairs committee goes on to say:

The committee has raised concerns in previous reports regarding over-reliance on subordinate legislation to implement significant amendments and reform, and has ... noted the importance of timely provision of subordinate legislation for committee scrutiny.

Unfortunately—or perhaps I should say fortunately—the opposition is not about to simply accept the government’s view that they are committed to due process. The government say: ‘Don’t you worry about that. The regulations will be all right because we tell you so.’ As Senator Colbeck pointed out, there has not been time to properly scrutinise the regulations, nor were any of the witnesses in a position to comment on what they might have perceived as flaws in those regulations. These are the people who have some expertise in appearing before the PBAC and making submissions to the PBAC. They were all very concerned about what it would mean. For instance, I turn to comments by Professor Ravenscroft, from Palliative Care Australia. He said:

My personal comment is that to leave this open for the bureaucracy to make these decisions—

that is, about what constitutes an orphan drug, about what small volume drugs should have extensions to their indicator use—

may end up producing a result that is less than satisfactory for the patients who need these drugs.

The problem that has developed is that we have no idea how any of this will work in practice. The people who have the best expertise and the best chance to tell us how this would work in practice had no opportunity to tell us this information because it was not available. We are, I am afraid, somewhat cynical about the government telling us: ‘Don’t you worry about that. We’ll get it right.’

I would like to talk a little about the effects of this on the smaller groups such as the palliative care part of the health industry in Australia. There are 135,000 or so deaths in Australia every year. About 100,000 of those are related to people who have had an illness before they die. We know that presently 40,000 to 50,000 people a year in Australia need care in the terminal phase of their illness. Of those people, 25 per cent die at home being cared for by their families and loved ones. A perhaps more disturbing figure is that 80 per cent of those 50,000 people would like to stay at home, they would like to be treated at home, and yet only 25 per cent are. These are people suffering from a wide range of terminal illnesses and certainly in need of our support, our empathy and our help.

There was some evidence given during the inquiry that told us that many drugs that are currently used in large population groups, such as for epilepsy, could be of benefit being used for pain management purposes in the palliative care market. To do this requires a new submission, for an extension of the indicators, to the PBAC. Right now there are people with terminal illness being treated in hospitals because the drugs they need cannot be administered anywhere except in hospital because they are not on the PBS. We have that problem right now. How much worse can that get when orphan drugs, drugs for low-population groups, may in fact not get to be submitted to the PBAC? Yet this is a situation that we currently have no clarity whatsoever around. What is the public interest? Who decides? Where is the transparency in the draft regulations that are currently in place?

Professor Ravenscroft explained the situation to the committee. There are many drugs that currently exist to help palliative patients undergoing palliative care but the clinical studies for those drugs have not been done for palliative care purposes. There needs to be new data generated, at a cost. There need to be trials of the use of the drug, at a cost. If and when enough data is generated then these drugs go to the TGA for extension, at a cost. They go to the PBAC potentially, at a cost. Who is going to do this when we are talking about a low and disparate population group? We are talking about roughly 50,000 people. They have numerous problems—numerous needs for numerous different drugs. So we are talking about very, very small population groups that are not going to attract the attention or the funding that is needed from the drug companies.

There was also evidence given that community and industry organisations are free to bring submissions for listing with the PBAC to the PBAC. From the evidence given it appears that this has never happened. The palliative care medical profession at one stage investigated doing this because of the need for drugs in the palliative care industry and the fact that it is such a low-volume industry, but they could not get the funding needed to undertake the work that had to be done.

So the PBAC assessment process means that, in fact, most medicines are submitted to the PBAC for their major indicator. It is the first thing sought by the companies. There are many examples where drugs that have been used in palliative care are used off licence by palliative care physicians because the drug, whilst registered for the PBAC, still has not been through the regulatory mechanism for use by people having palliative care.

Two examples given during our evidence are worth bringing to the Senate’s attention because, in my view, they put a personal face, a real human aspect, to the sorts of issues we are currently talking about. The drug gabapentin is a reasonably new anti-epilepsy drug that is used for resistant epilepsy in the broader Australian community. It has proved to be a good drug for pain control in some areas. Currently, the palliative care group are asking whether, as an orphan drug, this drug would be able to work its way through the system. Will it be allowed to go through the system in a free way? We do not know. That is the point—we do not know. They cannot tell. No-one knows whether this would go through the system or not.

A second drug is octreotide, which has been approved for growth hormone treatment and for the treatment of a specific type of tumour. It is not available to the palliative care market, except in this off-label way. It is used much in the palliative care market for treating terminal gut obstruction where the patient has a tumour that is blocking their intestines and therefore causing the person to vomit copiously and to be in severe pain most of the time. The only place someone can get that drug right now is in a hospital, and a regular dosage of it outside the public system would cost well over $300 a week.

We are talking about one group of people here. Gut obstruction in the palliative care area affects about 10 per cent of those 50,000 people we were talking about before. This is not a group that any drug company is going to be seeking to make a submission about to the PBAC. In fact, we were given evidence that whilst the palliative care industry had asked the company to submit on this basis they were not prepared to do that, even now in the current system, because of the cost to the company. We need a lot more certainty than we currently have about what will be considered an orphan drug or a low-population drug and therefore will be able to be put through at someone’s discretion. We are not entirely sure whose discretion it will be. It will be discretionary, but at whose discretion we do not know.

The other thing that witnesses were concerned about was the stage of the process at which they would know whether there would be costs involved with submitting to the PBAC. Why would a drug company go through the effort of putting up submissions, for instance, around what they considered to be an orphan drug or a low-population drug to subsequently discover that it was not to be assessed in that way? At what stage, at what point in the cost cycle, would companies know whether they had to fork out for their submission or not?

I suggest that the government might like to consider some of the other ways that companies in other countries go about putting medication into the system. There is, for instance, a process under the FDA where companies are given priority for listing low-population or orphan drugs depending on the work that they have done in the larger and wider community. A company might look at listing a low-population or orphan drug to potentially earn brownie points towards the listing of another drug which is going to be more profitable and therefore a way for them to write off or subsidise the costs of putting the orphan drug or the low-population drug into the system.

The coalition, as Senator Colbeck has pointed out, will not be supporting this legislation. We certainly accept that the PBS has ever-increasing costs and that these must be recouped, must be controlled and must be monitored. These costs will continue to rise. However, it is irresponsible to say: ‘Let’s worry about controlling the costs irrespective of the processes. We do not care what this is going to do or how it is going to do it. Let’s just get it in. Trust us. It will all be all right in the end because we say so.’ We would say to the government, a government so keen on process: ‘Sorry, get the process right and then this legislation will be very worthy of consideration—but when the process is right.’ Without careful analysis of the regulations, especially by those bodies that will have to live and be assessed under these regulations, it would be hypocritical of the government, I would suggest, to think that rushing this through makes some sort of positive difference to the PBS system. Clearly, a delay in here to do this properly would have cost very little in monetary terms. It would have given a lot of comfort to the industry and it would have been a very sensible way to progress this issue.